Benign Prostatic HyperplasiaNCT05236634
(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia
A study testing Phosphodiesterase 5 Inhibitors, Alpha Blockers and Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors in people with Benign Prostatic Hyperplasia, run by Assiut University.
Trial summary
To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Phosphodiesterase 5 Inhibitors, Alpha Blockers and Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 - Men > 45 years with LUTS/BPH for > 6 months 2- IPSS of ≥ 8 and Qmax of ≥ 4 to≤ 15 mL/s
Who cannot join
- PSA level of > 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).
- Post-voidresidual urine volume of ≥ 150 mL.
- Previous Urine Retention or Urethral Catheterization .
- other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .
- Any case of LUTS other than BPH (urinary bladder stone, neurogenic bladder, bladder neck contracture,rethral stricture, bladder cancer, acute or chronic prostatitis, acute or chronic urinary tract infection).
- patients supposed to undergo intraocular operation (as cataract operation) .
Show all 11Show fewer
- History of head injury or cerebrovascular stroke or spinal injury.
- pelvic fracture.
- Uncontrolled diabetic patient.
- Patients with chronic obstructive lung disease on medical treatment.
- Parasympatholytic drugs are contraindicated during the study. 12. Patients refusing to share in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Fixed Dose Monotherapy (Phosphodiesterase 5 Inhibitors or Alpha Blockers) Versus Combined Therapy in Benign Prostatic Hyperplasia Patients With Lower Urinary Tract Symptoms
To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.
Read the detailed description
The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia .
Benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS).
Alpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011.
The PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH.
Medical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH.
The inclusion of Tadalafil in complex of combined conservative therapy of patients with BPH not only improves sexual function but has a positive effect on symptoms of the disease and the psychological state of the patient.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Phosphodiesterase 5 Inhibitors, Alpha Blockers, Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors
- Keywords
- Phosphodiesterase5 inhibitors and Alpha Blockers
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphodiesterase 5 InhibitorsDrug
Also called tadalafil 5 mg oral Tablet
A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
Alpha BlockersDrug
Also called Tamsulin 0.4 mg oral tablet
A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
Combined Alpha Blockers and Phosphodiesterase 5 InhibitorsDrug
Also called Tadalafil 5 mg oral Tablet and Tamsulin 0.4 mg oral tablet
A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Receives: Drug: Alpha Blockers |
| Group B | Active comparator | Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Receives: Drug: Phosphodiesterase 5 Inhibitors |
| Group C | Active comparator | Forty patients with LUTS due to BPH will be given combined therapy(tamsulosin 0.4 mg and tadalafil 5 mg) for 12 weeks. Receives: Drug: Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International prostate symptom score (IPSS) after 12 weeks
The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Measured: At start of study and after 12 weeks from drug intake
Change in International index of erectile function (IIEF) after 12 weeks
The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity.
Measured: At start of study and after 12 weeks from drug intake
Change in Maximal urinary flow rate (Qmax) after 12 weeks
The flow rate is calculated as milliliters (ml) of urine passed per second. Both average and top flow rates are measured. The fastest flow rate, also known as Qmax, is used to understand if a block or obstruction is severe.
Measured: At start of study and after 12 weeks from drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into 3 groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Hussein Mostafa, Assiut University
- Investigators
- Mohamed E Osman, MD, Study chair, Assiut University, Urology department, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236634
- Sponsor's protocol ID
- Drug therapies in BPH
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singh DV, Mete UK, Mandal AK, Singh SK. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med. 2014 Jan;11(1):187-96. doi: 10.1111/jsm.12357. Epub 2013 Oct 25.
PubMed 24165272Wang XH, Wang X, Shi MJ, Li S, Liu T, Zhang XH. Systematic review and meta-analysis on phosphodiesterase 5 inhibitors and alpha-adrenoceptor antagonists used alone or combined for treatment of LUTS due to BPH. Asian J Androl. 2015 Nov-Dec;17(6):1022-32. doi: 10.4103/1008-682X.154990.
PubMed 25994648Mirone V, Sessa A, Giuliano F, Berges R, Kirby M, Moncada I. Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events. Int J Clin Pract. 2011 Sep;65(9):1005-13. doi: 10.1111/j.1742-1241.2011.02731.x. Epub 2011 Jul 1.
PubMed 21718399
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Fixed Dose Monotherapy (Phosphodiesterase 5 Inhibitors or Alpha Blockers) Versus Combined Therapy in Benign Prostatic Hyperplasia Patients With Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT05236634
- Acronym / sponsor ID
- Drug therapies in BPH
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Phosphodiesterase5 inhibitors and Alpha Blockers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.
Detailed description
The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia .
Benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS).
Alpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011.
The PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH.
Medical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH.
The inclusion of Tadalafil in complex of combined conservative therapy of patients with BPH not only improves sexual function but has a positive effect on symptoms of the disease and the psychological state of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into 3 groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Alpha BlockersForty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. |
| Group B | Active comparator | Drug: Phosphodiesterase 5 InhibitorsForty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. |
| Group C | Active comparator | Drug: Combined Alpha Blockers and Phosphodiesterase 5 InhibitorsForty patients with LUTS due to BPH will be given combined therapy(tamsulosin 0.4 mg and tadalafil 5 mg) for 12 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 - Men > 45 years with LUTS/BPH for > 6 months 2- IPSS of ≥ 8 and Qmax of ≥ 4 to≤ 15 mL/s
Key exclusion criteria (11 listed)
- PSA level of > 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).
- Post-voidresidual urine volume of ≥ 150 mL.
- Previous Urine Retention or Urethral Catheterization .
- other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .
- Any case of LUTS other than BPH (urinary bladder stone, neurogenic bladder, bladder neck contracture,rethral stricture, bladder cancer, acute or chronic prostatitis, acute or chronic urinary tract infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphodiesterase 5 InhibitorsAlso: tadalafil 5 mg oral TabletA total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks. | Drug | Group B |
| Alpha BlockersAlso: Tamsulin 0.4 mg oral tabletA total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks. | Drug | Group A |
| Combined Alpha Blockers and Phosphodiesterase 5 InhibitorsAlso: Tadalafil 5 mg oral Tablet and Tamsulin 0.4 mg oral tabletA total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks. | Drug | Group C |
Primary outcome
Change in International prostate symptom score (IPSS) after 12 weeks
Time frame: At start of study and after 12 weeks from drug intake
The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Change in International index of erectile function (IIEF) after 12 weeks
Time frame: At start of study and after 12 weeks from drug intake
The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity.
Change in Maximal urinary flow rate (Qmax) after 12 weeks
Time frame: At start of study and after 12 weeks from drug intake
The flow rate is calculated as milliliters (ml) of urine passed per second. Both average and top flow rates are measured. The fastest flow rate, also known as Qmax, is used to understand if a block or obstruction is severe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 24165272Singh DV, Mete UK, Mandal AK, Singh SK. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med. 2014 Jan;11(1):187-96. doi: 10.1111/jsm.12357. Epub 2013 Oct 25.
- Background: PubMed 25994648Wang XH, Wang X, Shi MJ, Li S, Liu T, Zhang XH. Systematic review and meta-analysis on phosphodiesterase 5 inhibitors and alpha-adrenoceptor antagonists used alone or combined for treatment of LUTS due to BPH. Asian J Androl. 2015 Nov-Dec;17(6):1022-32. doi: 10.4103/1008-682X.154990.
- Background: PubMed 21718399Mirone V, Sessa A, Giuliano F, Berges R, Kirby M, Moncada I. Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events. Int J Clin Pract. 2011 Sep;65(9):1005-13. doi: 10.1111/j.1742-1241.2011.02731.x. Epub 2011 Jul 1.
- Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TR, Mamoulakis C, Rieken M, Speakman MJ and Tikkinen KA. (2015): Guidelines on the management of non neurogenic male (LUTS), incl. (BPO). EAU GuidelinesLink provided by the sponsor.
- Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TRW, Mamoulakis C, et al. Management of nonneurogenic male LUTS. In: EAU Guidelines 2020. Arnhem,The Netherlands: EAU Guidelines Office; 2020. Available from:https://uroweb.org/guideline/treatment-of-nonLink provided by the sponsor.
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed E Osman, MD study chair
Assiut University, Urology department, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Phosphodiesterase 5 Inhibitors, Alpha Blockers and Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors in people with Benign Prostatic Hyperplasia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Hussein, Master (01004744048 ext. 002, ahmedawd99991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International prostate symptom score (IPSS) after 12 weeks (time frame: At start of study and after 12 weeks from drug intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236634, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.